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Fibrinolytic parameters in women with heavy menstrual bleeding


- candidate number19442
- NTR NumberNTR4823
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-sep-2014
- Secondary IDsNL50151.042.14 
- Public TitleFibrinolytic parameters in women with heavy menstrual bleeding
- Scientific TitleSystemic fibrinolysis in women with heavy menstrual bleeding
- ACRONYMMenorrhagia and systemic fibrinolysis
- hypothesis
- Healt Condition(s) or Problem(s) studiedMenorrhagia, Cyclic heavy bleeding, Fibrinolysis, Coagulopathy
- Inclusion criteriaInclusion criteria for patients:
- Patients with regular heavy menstrual bleeding (=menorrhagia).
- Age over 18 years.
- Written informed consent.
Inclusion criteria for healthy controls with regular menstrual blood loss:
- Age over 18 years.
- Written informed consent.
- Exclusion criteriaExclusion criteria for patients:
- Patients with postmenopausal, postcoital or intermenstrual bleeding
- Patients with an intra-uterine device or hormonal treatment.
- Patients with anticoagulant, antithrombotic therapy or use of non-steroidal anti-inflammatory drugs (NSAIDís).
- Patients with uterine fibroids > 2 cm in diameter.
- Patients with a Body Mass Index >30 kg/m2.
- Patients with a Pictorial Bleeding Assessment Chart-score <200.
Exclusion criteria for healthy controls:
- Women with postmenopausal, postcoital or intermenstrual bleeding.
- Women with an intra-uterine device or hormonal treatment.
- Women with anticoagulant, antithrombotic therapy or use of non-steroidal anti-inflammatory drugs (NSAIDís).
- Women with a Body Mass Index >30 kg/m2.
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-nov-2014
- planned closingdate1-mei-2015
- Target number of participants20
- InterventionsPatients ar asked to fill out a questionnaire and to withdraw blood 4 times (one time every week, for 4 weeks in a row).
- Primary outcome- Investigate the cyclic variation in clot lysis time in women with HMB in comparison to controls.
- Secondary outcome- Investigate the cyclic variation in TAFI, PAI-1, tPA, PI, thrombin generation, fibrin clot permeation and confocal microscopy analysis of fibrin clots in women with HMB in comparison to controls.
- Investigate the ovulatory menstrual cycle by measuring progestagen.
- TimepointsOverview of measurements during the study
- Questionnaire: week 1
- PBAC: week 1
- Blood: Fibrinolytic parameters: week 1,2,3, 4
- Blood: Progesterone: week 3
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. S. Wiewel-Verschueren
- CONTACT for SCIENTIFIC QUERIESDrs. S. Wiewel-Verschueren
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsOur previous research on this topic is published:
Titel: No increased fibrinolysis in women with heavy menstrual bleeding.
Authors: Wiewel-Verschueren S, Knol HM, Lisman T, Bogchelman DH, Kluin-Nelemans JC, van der Zee AG, Mulder AB, Meijer K.
Published: J Thromb Haemost. 2014 Sep;12(9):1488-93.
- Brief summaryHeavy menstrual bleeding (HMB) is known to be associated with gynaecological abnormalities and can also be associated with a wide range of haemostatic disorders. There is also evidence that fibrinolysis in the endometrium plays an important role in menstruation. The role of systemic fibrinolysis in women with heavy menstrual bleeding was studied and showed no increased systemic fibrinolysis in women with heavy menstrual bleeding. Certain fibrinolytic parameters were even higher in patients with heavy menstrual bleeding. An explanation why we found no increased systemic fibrinolysis could be the moment of testing in the menstrual cycle. Probably there is cyclic variation in menstruating women with menorrhagia. This hypothesis needs to be tested by measuring fibrinolytic parameters during the menstrual cycle in women with HMB and controls with normal menstrual bleeding.
- Main changes (audit trail)
- RECORD11-sep-2014 - 29-okt-2014


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